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Sitagliptinm onotherapycom paredwith placebo ChangeinF PG ChangeinPPG Changeinweight Percentrequiring ChangeinA1c from from baselineat from baselineat Percentachieving from baselineat rescuem edication Author purchase 1.5mg exelon overnight delivery medicine 029,year baselineat(%) (m g/dL ) (m g/dL ) A1c <7% (kg) (%) S100 PBO S100 PBO S100 PBO S100 PBO S100 PBO S100 PBO 12weeks 12weeks 12weeks 12weeks 12weeks 12weeks N onaka buy 4.5mg exelon amex treatment gout, a 49 -0 order zofran paypal. Abbreviation:PBO ,placebo;S100,sitagliptin100m g daily;N R ,notreported. Diabetes Page 62 of 99 Final Report Drug Effectiveness Review Project Table18. Sitagliptincom paredwith anactiveagent Changeinweight Percentrequiring Author, ChangeinA1c from ChangeinF PG from ChangeinPPG from Percentachieving from baselineat rescuem edication a year baselineat(%) baselineat(m g/dL ) baselineat(m g/dL ) A1c <7% (kg) (%) S100 Glip S100 Glip S100 Glip S100 Glip S100 Glip S100 Glip 12weeks 12weeks 12weeks 12weeks 12weeks 12weeks Scott, b b 53 -0. Abbreviations:G lip,glipiz ide;M 1,m etform in1000m g/day;M 2,m etform in2000m g/day;S100,sitagliptin100m g daily;N R ,notreported. Diabetes Page 63 of 99 Final Report Drug Effectiveness Review Project F igure6. M eta-analysis of sitagliptinstudies forA1c Comparison: A1c(%) O utcome: Differencefrom control Study Sitagliptin Control Difference(random) Difference(random) orsub-category N N Difference(SE ) 95% CI 95% CI 100mg dailydose Aschner 2 2 9 2 4 4 - 0. M eta-analysis of sitagliptinstudies forweightloss : Comparison: W eightloss(kg) O utcome: Differencefrom control Study Sitagliptin Control Difference(random) Difference(random) orsub-category N N Difference(SE ) 95% CI 95% CI 100mg dailydose Aschner 2 2 9 2 4 4 0. Approximately 60% of patients were on more than 1 oral hypoglycemic agent, while 30% were on more than 2 oral agents (Table 15). Patients were considered to have “failed” therapy with metformin, pioglitazone, or glimepiride at screening or after 10-19 weeks of dose stabilization and if A1c was between 7-10% or 7. Patients also entered 2-week single-blind, placebo run-in periods prior to randomization. The addition of sitagliptin to metformin, pioglitazone, or glimepiride appears to show larger reductions in A1c and fasting plasma glucose compared with the addition of placebo over 24 weeks (Table 19). A larger proportion of sitagliptin-treated patients also achieved the A1c goal of <7% than placebo-treated patients (approximately 11%-47. Subjects who received placebo plus glimepiride showed worsening glycemic control, while subjects on placebo plus metformin or placebo plus pioglitazone had slight improvements or no change in A1c from baseline. Weight gain was generally seen in patients taking pioglitazone or glimepiride, with or without the addition of sitagliptin. Unlike the other studies , this trial evaluated the effects of sitagliptin in patients with worse glycemic control (baseline A1c between 8-11%). Of the 544 patients screened, 190 patients were randomized to treatment. These patients were on metformin and diet and exercise for 6 weeks, had baseline A1c between 8-11%, and had ≥85% adherence to their regimens during a 2-week, placebo run-in period. No patients were naïve to oral hypoglycemic agents and approximately 50% were already taking metformin monotherapy or combination oral therapy at baseline. The addition of sitagliptin to ongoing metformin therapy was more effective than placebo plus metformin at lowering A1c (placebo-corrected difference: -1.

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Two nigh tmean wk priorto screeningh aving W A SO ofatleast30 mins and received any substance with C N S TST between3 and 7 h our effects 58% female; N R / 1/ Placebo; each screeningnigh t R ace/eth nicity: 212 212 ; C aucasian90% ; A tscreening:65 years orolder Significantpsych iatricormedical M eanage (SD): N R / 0/ 9 weeks R amelteon 6mg exelon free shipping medicine 79,diagnosis ofch ronicprimary illness as determined by th e 70 generic 3mg exelon visa symptoms 5dpo. A t ramelteon)includingsleepaids and randomiz ation:meanL PS =20 h erbalpreparations with C N S mins on2 nigh ts with neith er effects order tricor on line amex,with in3 weeks ofbaseline nigh t<15 mins and a mean orwh o h ad flownacross more th an W A SO =60 mins with a wake 3 time z ones with in7 days of time =45 mins oneach ofth e 2 screening. A trandomiz ation: 63% female; N R / 0/ R amelteon8 nigh ts. A H I>15 orperiodiclegmovements mg; with arousalindex>20 onPSG. R ace/eth nicity: 100 100 Placebo; C aucasian:95% A sian:1% H ispanic:4% Black, N ative A merican, O th er:0% ; Insomnia 48 of 309 Final Report Update 2 Drug Effectiveness Review Project Evidence Table 3. C h aracteristics ofPlacebo-controlled trials ofnewerinsom niadrugs A uth or,year InclusionC riteria ExclusionC riteria Dem ograph ics N um ber N um ber Study Interventions (Q uality) Screened W ith drawn Duration Eligible L ostto followup Enrolled A nalyz ed R amelteon 4mg; R amelteon 8mg; Placebo; ; R oth 2006 A ge 65 years orolderwith a Patients could noth ave h ad any M eanage (SD): N R / 128/ 5 weeks R amelteon4 (F air) diagnosis ofprimary insomnia significantmedicalorpsych iatric 72. Body mass indexmust h ave beenbetween18 and 34, inclusive,and h abitualbedtime musth ave beenbetween8:30 pm and 12:00 am. F orsubset ofpatients with severe sleep onsetdifficulties (sSL =60) 0% female; N R / N R / R amelteon8 receiving8 mgorplacebo were mg; included inposth ocanalysis R ace/eth nicity:N ot 829 N R Placebo; reported ; Sch arf,2005 M enand womenbetweenth e Patients with a priorh istory of M eanage (SD): 353/ 21/ 14 days Esz opiclone (F air) ages of65 and 85 years wh o allergies to z opiclone orany 72. C h aracteristics ofPlacebo-controlled trials ofnewerinsom niadrugs A uth or,year InclusionC riteria ExclusionC riteria Dem ograph ics N um ber N um ber Study Interventions (Q uality) Screened W ith drawn Duration Eligible L ostto followup Enrolled A nalyz ed excluded. R ace/eth nicity:N R 119 119 Placebo; ; Insomnia 50 of 309 Final Report Update 2 Drug Effectiveness Review Project Evidence Table 3. C h aracteristics ofPlacebo-controlled trials ofnewerinsom niadrugs A uth or,year InclusionC riteria ExclusionC riteria Dem ograph ics N um ber N um ber Study Interventions (Q uality) Screened W ith drawn Duration Eligible L ostto followup Enrolled A nalyz ed Soares 2006 W omenaged 40-60 yrs wh o obstructive sleepapnea,h istory of M eanage (SD):49 642/ 51/ 4 weeks Esz opiclone; metDSM -IV criteria for substance abuse ordependence, (); insomnia inth e contextof consumptionofmore th an2 menopausaltransition,peri alcoh olicbeverages perday or14 menopausalorearly post perweek,use ofprescription menopausalwith variable cycle medications knownto affectsleep, length ;late menopausal and th e use ofoverth e counter transitionwith two ormore medicationaffectingsleepormood. Sleeplatency >= 45 minand sleepduration <= 6h ,>= 3x/wk for1 month ; insomnia symptoms post-date 100% female; N R / N R / ; onsetofperi-menopausal R ace/eth nicity: 410 410 ; symptoms,with no oth ercause C aucasian:77% ofsecondary insomnia Black:15% H ispanic:8% ; Soubrane DSM -IV-defined primary A ny DSM -IV A xis I psych iatric M eanage (SD): N R / 20/ 3 weeks Z olpidem M R ; (poster)(F air) insomnia,W A SO 1 h ourper disorder,sleepdisorder,h istory of 44. C h aracteristics ofPlacebo-controlled trials ofnewerinsom niadrugs A uth or,year InclusionC riteria ExclusionC riteria Dem ograph ics N um ber N um ber Study Interventions (Q uality) Screened W ith drawn Duration Eligible L ostto followup h ours pernigh tduringth e 2 counterorprescriptionsleep Enrolled A nalyz ed weeks priorto enrollment. C aucasian,10% oth er ; Terz ano, patients metth e criteria forth e patients h ad nocturnalmyoclonus M eanage (SD): N R / N R / 1 days Z olpidem; 1992 (Poor) diagnosis ofpersistent orsleepapnea syndrome 49. W A SO ofatleast30 circadianrh yth m disorder, mins oneach nigh twith a parasomnia,and dyssomnia), meanW A SO ofatleast40 h istory ofepilpesy,parasomnia and mins,a totalsleeptime of dissomnia),h istory ofepilepsy, between3 and 7 h ours on myasth enia gravis,evidence ofany each nigh t clinically significant,severe or unstable progressive,progressive, medicalorsurgicaldisorder,h isotry ofsubstance abuse,lifestyle th at precludes diagnosis ofprimary insomnia,use ofsleepmedication inth e previous 2 weeks, concommitantuse ofany psych otropicdrugoroth er substance knownto affectsleep with inth e previous week. Insomnia 52 of 309 Final Report Update 2 Drug Effectiveness Review Project Evidence Table 3. C h aracteristics ofPlacebo-controlled trials ofnewerinsom niadrugs A uth or,year InclusionC riteria ExclusionC riteria Dem ograph ics N um ber N um ber Study Interventions (Q uality) Screened W ith drawn Duration Eligible L ostto followup p Enrolled A nalyz ed 57% female; N R / 0/ Placebo; R ace/eth nicity: 205 203 ; W h ite:95. Patients h ad to be off ofoth erinsomnia medications at 0% female; N R / 80/ Placebo; screening. R ace/eth nicity: 830 828 ; ; Insomnia 53 of 309 Final Report Update 2 Drug Effectiveness Review Project Evidence Table 3. C h aracteristics ofPlacebo-controlled trials ofnewerinsom niadrugs A uth or,year InclusionC riteria ExclusionC riteria Dem ograph ics N um ber N um ber Study Interventions (Q uality) Screened W ith drawn Duration Eligible L ostto followup Enrolled A nalyz ed W alsh ,2000a M ales and female aged 60 to any ch ronicorrecurrentmedical M eanage (SD): 311/ N R / 2 days Z aleplon2mg; (Poor) 80 years wh o reported sleep illness considered to affectsleepor 67. A dditionally,patients with criteria included th e following a presentorpasth istory ofa major occurringth ree ormore times psych iatricillness [e.

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Erosive gastroesophageal reflux disease short-term trials of proton pump inhibitor compared with proton pump inhibitor Author Withdrawals Due to Year Results by Baseline Severity Adverse Events Quality rating Funding source Chen et al generic 1.5 mg exelon mastercard brazilian keratin treatment, Not quantitatively expressed order cheap exelon line medications bad for kidneys, see Figure 1 cheap atrovent 20 mcg mastercard. NR Fair NR (AstraZeneca 2005 Difference stated as not SS different. Erosive gastroesophageal reflux disease short-term trials of proton pump inhibitor compared with proton pump inhibitor Number Screened, Eligible, Enrolled, Author Esophagitis Grade (Grading Withdrawn, Lost to Year Population, Setting Criteria), Other Characteristics Followup Healing Rate at 4 Weeks Fennerty, 2005 999 patients at multiple Grade C: 79% 4015 screened/ esomeprazole 40 mg: 55. Erosive gastroesophageal reflux disease short-term trials of proton pump inhibitor compared with proton pump inhibitor Author Year Healing Rate at 8 Weeks Symptoms at 4 Weeks Symptoms at 8 Weeks Fennerty, 2005 esomeprazole 40 mg: 77. Erosive gastroesophageal reflux disease short-term trials of proton pump inhibitor compared with proton pump inhibitor Author Withdrawals Due to Year Results by Baseline Severity Adverse Events Quality rating Funding source Fennerty, 2005 Grade C 5/499 (1%) Good AstraZeneca Healing at 4 weeks esomeprazole vs 9/502 esomeprazole 40 mg: 60. Erosive gastroesophageal reflux disease short-term trials of proton pump inhibitor compared with proton pump inhibitor Number Screened, Eligible, Enrolled, Author Esophagitis Grade (Grading Withdrawn, Lost to Year Population, Setting Criteria), Other Characteristics Followup Healing Rate at 4 Weeks Gillessen, 2004 227 patients at 27 centers in Grade B: 84% pantoprazole, 83% Screened NR/eligible "Early time points" (4 and 6 weeks) Germany. Erosive gastroesophageal reflux disease short-term trials of proton pump inhibitor compared with proton pump inhibitor Author Year Healing Rate at 8 Weeks Symptoms at 4 Weeks Symptoms at 8 Weeks Gillessen, 2004 "Late time points" (8 and 10 Overall relief of symptoms Overall relief of symptoms weeks) Per-protocol (N=197): Per-protocol (N=197): Intention-to-treat (N=227): pantoprazole 40 mg: 37% pantoprazole 40 mg: 47% pantoprazole 40 mg: 90% esomeprazole 40 mg: 35% esomeprazole 40 mg: 32% esomeprazole 40 mg: 92% (NS for PP or ITT) (NS for PP or ITT) (NS) Per-protocol (N=197): After 10 weeks: pantoprazole 40 mg: 96% pantoprazole 40 mg: 65% esomeprazole 40 mg: 93% esomeprazole 40 mg: 63% (NS) (NS for PP or ITT) Proton pump inhibitors Page 16 of 304 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 1. Erosive gastroesophageal reflux disease short-term trials of proton pump inhibitor compared with proton pump inhibitor Author Withdrawals Due to Year Results by Baseline Severity Adverse Events Quality rating Funding source Gillessen, 2004 Per-protocol, overall healing by baseline grade 6 patients overall, not Fair: Altana Pharma, Grade B: reported by group. Randomization, allocation concealment method Germany pantoprazole 40 mg: 92% not reported. Proton pump inhibitors Page 17 of 304 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 1. Erosive gastroesophageal reflux disease short-term trials of proton pump inhibitor compared with proton pump inhibitor Number Screened, Eligible, Enrolled, Author Esophagitis Grade (Grading Withdrawn, Lost to Year Population, Setting Criteria), Other Characteristics Followup Healing Rate at 4 Weeks Kao et al, 2003 100 patients at one center in Grade A: 51% Screened NR/eligible Not reported Taiwan Grade B: 49% NR/100 enrolled mean age 49 (Los Angeles Classification) 69% male 100% Asian Proton pump inhibitors Page 18 of 304 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 1. Erosive gastroesophageal reflux disease short-term trials of proton pump inhibitor compared with proton pump inhibitor Author Year Healing Rate at 8 Weeks Symptoms at 4 Weeks Symptoms at 8 Weeks Kao et al, 2003 Not reported Esomeprazole 40 mg vs omeprazole Efficacy of on-demand therapy (n=34 esomeprazole 40 mg, n=23 20 mg omeprazole 20 mg, initiated week 5) Per-protocol (N=91) Symptom-free on day 1: 28. Erosive gastroesophageal reflux disease short-term trials of proton pump inhibitor compared with proton pump inhibitor Author Withdrawals Due to Year Results by Baseline Severity Adverse Events Quality rating Funding source Kao et al, 2003 Not reported Not reported Fair: Supported by a grant not clear if patients masked, randomization, from the National allocation concealment methods not reported. Cheng Kung University Proton pump inhibitors Page 20 of 304 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 1. Erosive gastroesophageal reflux disease short-term trials of proton pump inhibitor compared with proton pump inhibitor Number Screened, Eligible, Enrolled, Author Esophagitis Grade (Grading Withdrawn, Lost to Year Population, Setting Criteria), Other Characteristics Followup Healing Rate at 4 Weeks Castell 1070 US patients at multiple Grade 2: 61%-71% 1284 enrolled, 1226 lansoprazole 15 mg: 72. Erosive gastroesophageal reflux disease short-term trials of proton pump inhibitor compared with proton pump inhibitor Author Year Healing Rate at 8 Weeks Symptoms at 4 Weeks Symptoms at 8 Weeks Castell lansoprazole 15 mg: 75. Erosive gastroesophageal reflux disease short-term trials of proton pump inhibitor compared with proton pump inhibitor Author Withdrawals Due to Year Results by Baseline Severity Adverse Events Quality rating Funding source Castell When healing rates were adjusted for baseline omeprazole 20 mg: 2% Fair: randomization and allocation method not Supported by TAP 1996 esophagitis grade, treatment comparison results lansoprazole 30 mg: reported, attrition not reported Pharmaceuticals, were similar to those of the overall analyses. Patients with less severe esophagitis (grade 2) at lansoprazole 15 mg: baseline had higher rates with all the active 0. Healing rate at 4 weeks, lansoprazole 15 mg vs lansoprazole 30 mg vs omeprazole 20 mg, by baseline esophagitis grade: grade 2: 83.

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